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510(k) K890825

JUMPER PACK #203 by O.R. Specialties, Inc. — Product Code HQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 1989
Date Received
February 17, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Phacofragmentation
Device Class
Class II
Regulation Number
886.4670
Review Panel
OP
Submission Type

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  • K922355 — POLLY'S VITREOUS SCISSORS J-225-S (August 18, 1992)
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  • K914038 — POLLY'S CUTTER J-225 (December 9, 1991)
  • K911932 — J105 JAMES SURGICAL SYSTEM I/A PACK (August 26, 1991)
  • K890195 — JAMES SURGICAL SYSTEM J1000 (August 3, 1989)

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